Registration of drugs, medical equipment and medical devices within the EAEU. Registration of dietary supplements.

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Registration of drugs, medical equipment and medical devices within the EAEU. Registration of dietary supplements.

 

 

A full range of services to support the process of registration, re-registration, introduction of amendments to registration dossiers for medicinal products, dietary supplements to food, medical devices and medical equipment.

 

 

ADALAN   operates in the following countries:

  • Kazakhstan;
  • Georgia
  • Belarus
  • Kyrgyzstan;
  • Uzbekistan;
  • Turkmenistan;
  • Tajikistan;
  • Mongolia.

Launched the procedure for registration of drugs according to the unified rules of the EAEU

After the Decision No. 78 of the Board Eurasian Economic Commission (EEC) oN November 3rd, 2016, the “Rules” for registration and expert review of drugs for medical use within the Eurasian Economic Union (EAEU) were approved and entered into force on May 6th, 2017.
With a view to theese forthcoming changes, medicines registered under the “Rules” can circulate and be offered for sale throughout the EAEU, in the territories of Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan without undergoing any registration procedures in each of these member states.
In particular, the “Rules” provide two procedures for registration of medicines:
1) Mutual recognition: the registration is first conducted in the reference state at the applicant’s choice, then in the states of recognition at the applicant’s request;
2) Decentralised procedure: the registration is conducted simultaneously in several member states in which an application has been filed, one of which is chosen as the reference state.
 In addition, for registration dossiers of medicines registered in the member states under the national requirements before 31 December 2020, it is necessary to conduct the Bringing into Compliance procedure with the EAEU requirements until 31 December 2025.

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